Form Cms-116 - Clinical Laboratory Improvement Amendments Of 1988 (Clia) Application For Certification Page 3
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9In the next three sections, indicate testing performed and annual test volume.
VI. WAIVED TESTING
Identify the waived testing (to be) performed. Be as specific as possible. This includes each analyte test system or device used
in the laboratory.
e.g. (Rapid Strep, Acme Home Glucose Meter)
Indicate the ESTIMATED TOTAL ANNUAL TEST volume for all waived tests performed ________________
Check if no waived tests are performed
VII. PPM TESTING
Identify the PPM testing (to be) performed. Be as specific as possible.
e.g. (Potassium Hydroxide (KOH) Preps, Urine Sediment Examinations)
Indicate the ESTIMATED TOTAL ANNUAL TEST volume for all PPM tests performed ________________
For laboratories applying for certificate of compliance or certificate of accreditation, also include PPM test volume in the
specialty/subspecialty category and the “total estimated annual test volume” in section VIII.
Check if no PPM tests are performed
If additional space is needed, check here
and attach additional information using the same format.
VIII. NON-WAIVED TESTING (Including PPM testing if applying for a Certificate of Compliance or Accreditation)
If you perform testing other than or in addition to waived tests, complete the information below. If applying for one
certificate for multiple sites, the total volume should include testing for ALL sites.
Place a check (3) in the box preceding each specialty/subspecialty in which the laboratory performs testing. Enter the
estimated annual test volume for each specialty. Do not include testing not subject to CLIA, waived tests, or tests run for quality
control, calculations, quality assurance or proficiency testing when calculating test volume. (For additional guidance on counting
test volume, see the instructions included with the application package.)
If applying for a Certificate of Accreditation, indicate the name of the Accreditation Organization beside the applicable specialty/
subspecialty for which you are accredited for CLIA compliance. (The Joint Commission, AOA, AABB, CAP, COLA or ASHI)
ANNUAL
SPECIALTY /
ACCREDITING
ANNUAL
SPECIALTY /
ACCREDITING
TEST
SUBSPECIALTY
ORGANIZATION TEST VOLUME
SUBSPECIALTY
ORGANIZATION
VOLUME
HISTOCOMPATIBILITY 010
HEMATOLOGY 400
Transplant
Hematology
IMMUNOHEMATOLOGY
Nontransplant
MICROBIOLOGY
ABO Group & Rh Group 510
Bacteriology 110
Antibody Detection (transfusion) 520
Mycobacteriology 115
Antibody Detection (nontransfusion) 530
Mycology 120
Antibody Identification 540
Parasitology 130
Compatibility Testing 550
PATHOLOGY
Virology 140
DIAGNOSTIC IMMUNOLOGY
Histopathology 610
Syphilis Serology 210
Oral Pathology 620
General Immunology 220
Cytology 630
CHEMISTRY
RADIOBIOASSAY 800
Routine 310
Radiobioassay
CLINICAL CYTOGENETICS 900
Urinalysis 320
Endocrinology 330
Clinical Cytogenetics
TOTAL ESTIMATED ANNUAL TEST VOLUME:
Toxicology 340
Form CMS-116 (05/15)
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